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Completed

NCT Number: NCT04772586

Sarcopenia and Mechanical Ventilation in Older Patients Admitted Due to COVID-19

The SarcoV study aims at assessing the association between sarcopenia and the indication of mechanical ventilation in older hospitalized patients due to COVID-19 infection

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Key information

Conditions

Sarcopenia Atrophy COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nidovirales Infections Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brugmann university hospital

Brussels, 1020, Belgium

About this study

Sarcopenia is disease associated with poor clinical outcomes. In critical ill chirurgical patients, sarcopenia is associated with difficult to wean of mechanical ventilation. The association between sarcopenia and mechanical ventilation is poorly studied in medical patients. COVID-19 pandemic has led a lot of medical patient to be admitted in intensive care units due to acute respiratory failure with need of mechanical ventilation support.

The primary objective is to determine if sarcopenia in critically-ill older patients with COVID-19 is associated with the indication of mechanical ventilation. Secondarily, the study aims at determining if sarcopenia is associated with difficult to wean and mortality in critically-ill older patients with COVID-19.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consecutive patients aged 60 and older
  • Admission in an acute care unit in Brugmann university hospital due to a COVID-19 possible or confirmed infection. A infection was considered confirmed in presence of a positive molecular test by Polymerase-chain reaction (PCR), following the Belgian Public Health Department recommendations (Sciensano recommendations).

Exclusion criteria

  • Patients unable to perform a grip-strength measurement due to any rheumatological or neurological condition.

Treatment and study plan

Primary outcomes

  1. Indication of mechanical ventilation

    Time frame: Through study completion, an average of 60 days

    Association between probable sarcopenia and the indication of mechanical ventilation in patients with COVID-19 infection.

    Mechanical ventilation was considered by non-invasive ventilation or invasive ventilation. For purpose of analysis, it was defined as a binary outcome (yes(no).

    Probable sarcopenia probable was defined according to the revised European consensus on definition and diagnosis of sarcopenia (EWGSOP2). For purpose of analysis, it was defined as a binary condition (yes/no).

Secondary outcomes

  1. Evaluate difficult-to-wean in mechanical ventilation

    Time frame: Through study completion, an average of 60 days

    Difficult to wean in mechanical ventilation is defined if the patient required more than 7 days of mechanical ventilation from the first spontaneous breath test or if the patient was reintubated within 48 hours after extubation. For purpose of analysis, it was considered as a binary outcome (yes/no)

  2. All-cause mortality

    Time frame: Through study completion, an average of 60 days

    Vital status during hospital admission, at 30- and 60-day follow-up

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Official study title

Sarcopenia and Mechanical Ventilation in Older Patient Admitted With COVID-19 Infection

Acronym: SARCO-V

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 26, 2021
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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